1 | Page

PV Express II for Public Submissions – Guidance Document 

Instructional Guidance for PV Express II for Public Submissions

NOTE: If you provide Personal Information when you submit an Adverse Event Report:

If you choose to provide us with personal information as in an email to one of our online email boxes, or by filling out a 

form with your personal information and submitting it to us through our website, we use that information to respond to 

your message and to help us get you the information you have requested. We do not collect personal information for 

any purpose other than to respond to you. We collect personally identifiable information (name, email address, or 

another unique identifier) only if specifically and knowingly provided by you. We only share the information you give us 

with another government agency if your inquiry related to that agency, or as otherwise required by law. Moreover, we 

do not create individual profiles with the information you provide or give it to any private organizations. We do not 

collect information for commercial marketing.

The PV Express II web-based form is the approved electronic method the public may use to submit individual adverse 

event reports (AER) for veterinary biological products to the Center for Veterinary Biologics (CVB). The PV Express II 

web-based form can be accessed here. The other approved methods the public may use to submit adverse event 

reports to the CVB is through hard copy submissions (email, mail, and fax).

The step-by-step instructions provided in this guidance document are to aid the public in completing the PV Express II 

web-based form.

NOTE: ALL FIELDS on the PV Express II web-based form should be completed if known by you. All date fields appear on 

the form as European dates (DD-MM-YYYY). To delete a case already submitted, contact CVB.

NOTE: Please consider reporting your adverse event report to the biological manufacturer. As of February 17, 2021, 

manufacturers are required to report all adverse event reports they receive to the CVB. If the case you are reporting has 

already been submitted to the manufacturer, there is no benefit to also filing the case with the CVB.

Should you have any questions, need assistance or need to report system problems, please contact 

CVB.Pharma@usda.gov or at (515) 337-6100.

_________________________________________________

https://cvbpv.aphis.usda.gov/PVXClient/index.html

Start the AER by clicking here.

URL to initiate an adverse event 

report.
2 | Page

PV Express II for Public Submissions – Guidance Document 

NOTE: Do NOT use the “Reporting for Manufacturers” link as your entry may be deleted. 

Then, clicking here.

Click on the Public Adverse 

Event Report.
3 | Page

PV Express II for Public Submissions – Guidance Document 

These 5 sections

contain mandatory

and optional 

requirements. Once 

the mandatory items 

are completed, the 

icon preceding the 

section name will 

change (eg. or ). 

Instructions for 

completing each 

section will be covered 

in this document.

These 4 sections allow 

for the reporting of 

additional products 

and reporters.

This final grouping 

allows you to check 

the report for errors, 

rename the report, or

delete the report.
4 | Page

PV Express II for Public Submissions – Guidance Document 

Case Overview 1: This is the screen as it initially appears. Mandatory fields are denoted with red asterisks (*). 

Remember, fill in ALL fields if they are known to you. Some fields have default values, which can be changed by 

selecting the down arrow at the right of the field. The down arrows at the right end of each field reveals a drop-down 

list to choose from.

The next picture shows the fields completed:
5 | Page

PV Express II for Public Submissions – Guidance Document 

The Country of Occurrence field defaults to 

United States

This section should 

contain information 

about the reporter, in 

this case Jim Smith. 

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left

corner of the screen.

Enter the establishment-assigned AER case 

number, if known.

The Case Type field defaults to Animal 

Complaint. If necessary, you can select

symptomatic human case. 

Choose from the drop-down list an 

appropriate reporter role, usually 

‘Owner/Producer/Employee’ or ‘Attending 

Veterinarian.’

Has the case been reported to the vaccine 

manufacturer? Select yes or no.
6 | Page

PV Express II for Public Submissions – Guidance Document 

Licensed Biological Product 1: This screen is as it initially appears. Enter information on this screen for your 

Establishment’s licensed product involved in this adverse event report. The down arrows at the right end of each field 

reveals a drop-down list to choose from.
7 | Page

PV Express II for Public Submissions – Guidance Document 

Choose a Product Role, usually 

‘Suspect product.’

Establishment and Product Code for 

the product involved with this 

adverse event report. The Licensed

Establishment information is 

available on the product label or 

from your veterinarian.

True name, Trade name, Serial number (if 

known) and expiration date of the product. 

This information is available on the product 

label or from your veterinarian. NOTE -

expiration date is in European format.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left

corner of the screen.

Start date = date of administration. End date 

is used when vaccination extends over a 

period of time (vaccinating 500 calves over 

two days, for example). If part of a series of 

immunizations for an individual animal, 

please explain in the case narrative.

Problem Type will usually be ‘Adverse 

reaction.’

If this value is less than 1 (<1), you 

must enter a zero followed by the 

decimal, for example “0.5”.

Enter the attending veterinarian’s 

assessment of causality, if known.

Choose the most appropriate response to 

these questions from the drop-down list.

Choose the route of administration and the 

site on the animal where administered.
8 | Page

PV Express II for Public Submissions – Guidance Document 

Event 1: This screen is as it initially appears. Enter information on this screen to describe the actual adverse event. 

Provide a complete, detailed narrative. The down arrows at the right end of a field reveals a drop-down list to choose 

from.

Click the drop-down arrow and 

select an outcome from the dropdown list.

If there is uncertainty about the 

date that the adverse event 

started, check this box.

How long did the adverse event last?

Provide a complete, detailed 

description (narrative) of the 

adverse event.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left 

corner of the screen.

The date the adverse event 

started.
9 | Page

PV Express II for Public Submissions – Guidance Document 

Patient 1: This screen is as it initially appears. Enter patient information. The down arrows at the right end of a field 

reveals a drop-down list to choose from.
10 | Page

PV Express II for Public Submissions – Guidance Document 

This completes the mandatory sections. 

If necessary, add additional ‘Licensed Biological Products’ or ‘Other Products’ (such as pharmaceuticals, heartworm 

medication, or flea control products, for example).

Provide the requested 

information regarding the 

animal.

Provide the number of animals 

exposed (vaccinated), the number 

reacted, and the number dead. If the 

numbers are approximations, check 

the box.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left 

corner of the screen.

Choose the appropriate species and 

breed from the drop-down lists.

If a mixed breed, check this box, 

and provide the other breed.
11 | Page

PV Express II for Public Submissions – Guidance Document 

Fill out all the fields as 

completely and accurately as 

possible.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left 

corner of the screen.

Select additional reporters from 

the drop-down list.

For the additional licensed 

biological products that were 

administered, select “Add 

Licensed Biological Product” and 

follow the instruction for Licensed 

Biological Product. Remember to 

select “Suspect product” for the 

Product role field. 

For any other products 

(pharmaceuticals, etc.) that were 

administered, select “Add Other 

Product” and complete all fields to 

the best of your ability.

To add additional reporters 

(owner, vet clinic), select “Add 

Reporter.” See example below.
12 | Page

PV Express II for Public Submissions – Guidance Document 

The final step involves checking the report for errors. If an error is found, you will be directed to correct the error and 

then allowed to submit the report.

If there are no errors, select continue:

You can rename the report (not necessary).

Enter a new name and then select 

“Rename.”
13 | Page

PV Express II for Public Submissions – Guidance Document 

Select “Submit report.”

You will get a “confirmation” screen:

Note the Report default name is 

“Public Report” and the Report ID. 

The Report ID is a useful field for 

CVB to find your report.

Select View summary. 

This will allow you to 

see, save, and print 

the report. This 

provides 

documentation of the 

report.

Files can be attached 

to your report, such as 

veterinarian records, 

etc., if necessary.
14 | Page

PV Express II for Public Submissions – Guidance Document 

Enlarged view of beginning of report.

 Enlarged view of bottom of report.

If desired, you can print the summary report for your records.

While too small to read in this 

picture, the summary contains all

of the data you entered into the 

report.
15 | Page

PV Express II for Public Submissions – Guidance Document 

Finally, select “Home” to start a new report or exit the AER web-based reporting application.